Pre-Clinical Writer - Niche product line - Cambridge
NonStops Client, a industry leader in natural pharmaceutical products is searching a Pre clinical writer to join their team.
This role gives you the opportunity to gain experience within a niche area of the industry, allowing you to build up a strong career profile, which will put you ahead of the completion.
As a Preclinical writer you duties will include:
, Prepare relevant preclinical sections of documents for Regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), New Drug Applications (NDA), Market Authorisation Applications (MAA), Orphan Drug Applications and Investigator Brochures (IB)
, Maintains an up-to-date knowledge of regulatory guidance to ensure appropriate preclinical data are available for regulatory submissions
, Prepares and manages the preparation of preclinical sections of briefing documents for meetings with competent authorities
, Coordinates with Regulatory Affairs Department
, Contributes to the preparation of SOPs for the Preclinical Department
, Organises quality control of required documents and / or sections as appropriate
To be successful in this role you should have:
, A graduate degree in a Science/Life Science discipline or another appropriate scientific discipline
, Good previous experience writing and reviewing preclinical study-related documents within the pharmaceutical, biotechnology and/or contract research organisations
, Strong scientific background
, Working knowledge of Word, Excel, PowerPoint, Endnote and search engines
, Excellent communication skills (written and verbal)
Skills which would be beneficial but not essential :
, Ability to QC documents
, Knowledge of appropriate regulatory guidelines and legislation
, Ability to assimilate and critique scientific writing
This position is based in Cambridge.
If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week.
Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Ruby Wallace, at firstname.lastname@example.org, or by calling me on 02079402105 for a discussion in confidence.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe.
We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry.
Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe.
Please visit our website for a full list of the niche markets we cover.
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